MAUDE Adverse Event Report: CIBA VISION CORPORATION DAILIES AQUACOMFORT PLUS LENSES, SOFT CONTACT, DAILY WEAR

Lot Number A0478438

Device Problems Entrapment of Device (1212); Product Quality Problem (1506); Torn Material (3024)

Patient Problems Corneal Ulcer (1796); Inflammation (1932); Foreign Body In Patient (2687)

Event Date 06/11/2017

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation. The device history record and sterilization record for this lot have been reviewed and found to be in compliance. There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint. The root cause could not be determined. (b)(4).

Event Description

It was initially reported by a consumer on 06/12/2017 that five contact lenses were torn during wear. It was reported by the consumer that upon removal of the contact lenses she could only take out either a torn piece of the contact lens or half of the contact lens. It was reported by the consumer that once she had to go to an eye care provider (ecp) due to an unspecified inflammation and an unspecified ulceration but the treatment modality and duration was not known. It was reported by the consumer that the ecp has removed the remaining part of the torn contact lens out of her eye. Additional information received from the consumer via email on 06/22/2017 stating that the eye inflammation and corneal ulcer happened on (b)(6) 2017. It was reported by the consumer that the left eye was involved and that it was "ulcerous". The consumer reported that she uses ¿levothyroxine sodium + liothyronine sodium¿ and an unspecified antibiotic drops as treatment, however the frequency and duration of both treatments are unknown. It was reported by the consumer that the event has resolved and that she is able to wear contact lenses again without problems. Additional information received from the consumer via email on 06/23/2017 clarifying that four contact lenses were torn during wear. No further information will be made available as the consumer refused to be contacted again.

• Brand Name: DAILIES AQUACOMFORT PLUS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION CORPORATION; 11460 johns creek parkway; duluth GA 30097
• Manufacturer (Section G): CIBA VISION CORPORATION; 11460 johns creek parkway; duluth GA 30097
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6702481
• MDR Text Key: 79655355
• Report Number: 1065835-2017-00020
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/30/2021
• Device Lot Number: A0478438
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2016
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 07/11/2017 Patient Sequence Number: 1